Dr. Bobby Smyth, a Child and Adolescent Psychiatrist penned a piece in the Irish Examiner attacking Gino Kenny’s Medical Cannabis Regulation bill entitled It’s time to smoke out the lies about cannabis’.

He argued that medical cannabis has “marginal value”  and that the enactment of the legislation would contribute to the  normalisation of cannabis, a trend that he associates with the problematic recreational use of “high potency” cannabis  by young people.

Dr. Smyth’s view that the bill is a “Trojan horse” to the legalisation of cannabis for recreational purposes had been previously stated by Dr. Harty (Chairperson of the Joint Committee on Health), the legislation’s only vocal opponent during the Oireachtas Second Stage debates.  Despite opposing the bill, Dr. Harty stated:

“I fully support legalising medicinal cannabis as a medical product and I believe it is important that the Dáil gets this legislation right”.

Gino Kenny`s bill will close gateways into the illicit recreational cannabis economy  for the thousands of Irish patients who may  benefit from cannabinoid-based medicines (cannabinoids are the primary ‘active constituents’ of cannabis). Currently, they must purchase cannabis from criminals, or cultivate/produce,  and possess the drug illegally; use a product which is of variable and unknown quality; and take it without medical guidance.

Cannabis in the blackmarket can contain dangerous levels of heavy metalspesticidesbacteria and mouldsGlass etching spray and other adulterants (including lead) may be added to increase weight.  Concentrations of cannabinoids are unknown, and a lack of medical guidance may lead to inefficient and ineffective treatment.    

In an informed public sphere, a large support for the legal availability of cannabinoid-based medicines is both understandable and justified. The representative Red C poll Help Not Harm commissioned suggests a support of 92% among the 18+ years Irish population. Every surveyed demographic was found to overwhelmingly support the availability of cannabinoid-based medicines.

Dr. Smyth is correct in stating  that the use of high potency cannabis amongst young people, their dependence on the drug, and the  interaction between this group and the criminal black market is a growing and troubling phenomenon.

American states that have enacted laws to allow for medical cannabis tend to have lower perceived harmfulness and higher levels of use amongst young people than states that do not. However, these trends appear to precede the enactment of such legislation; and evidence suggests that legislating for medical cannabis may increase the perception of harmfulness and decrease use in this population.

Concurrently, an emerging cannabinoid-based medicines industry could contribute resources to addressing the problematic recreational use of cannabis by young people. A social tax could be imposed on the incumbent industry with funds channelled to the HSE and/or Local and Regional Drug Task Forces to service at-risk young people and other key affected populations.

Funds could be used to address  underlying social determinants (e.g. housing status, educational attainsment, employment status); increase resilience in at-risk populations through targeted interventions ; and broaden access to specialised services.

Dr. Smyth’s statement that cannabinoid-based medicines provide “marginal value” appears to be in conflict with the, often drastic, benefits experienced by patients. Vera Twomey’s daughter Eva whose seizures decreased dramatically after using Charlotte’s Web Everyday Plus Hemp Extract Oil (a CBD-based preparation) is one example. Yvonne Cahalane’s son, Tristan who is essentially seizure free on another cannabinoid-based medicinal preparation, is another.  Both mothers were forced to move abroad to medical cannabis friendly jurisdictions to provide the necessary medical proof to justify compassionate exemptions by the Department of Health.  

The 2016 ‘Barnes’ report is testament to the fact that cannabis-based medicines do not have only “marginal value”.  Below is a summary of the evidence for the use of cannabis-based medicines according to American Academy of Neurology standards.

‘Barnes’ report summary

Good EvidenceModerate EvidenceLimited EvidenceTheoretical basis, but so far, no convincing evidence of efficacy
Chronic pain, including neuropathic pain;Sleep disorders;Management of agitation in dementia;Huntington’s disease;
Spasticity;Appetite stimulation in the context of chemotherapy;Epilepsy, particularly drug resistant childhood epilepsies;Headache;
Nausea and vomiting, particularly in context of chemotherapy;Fibromyalgia;Bladder dysfunction;’Brain protection in the context of traumatic brain injury;
Management of anxiety.Post-Traumatic Stress Disorder.Tourette’s syndrome.Depression;
Obsessive compulsive disorder;
Gastrointestinal disorders;
As an anti-psychotic agent (CBD);
and a role incancer/tumour control.

According to the Barnes report, the treatment of childhood epilepsy  with cannabinoid-based medicines has “low”evidence. It also found “low” evidence for the use of cannabinoid-based medicines in conditions such as glaucoma, and Tourette’s syndrome.  Despite “low” evidence, cannabinoid-based medicines can have dramatic and profoundly positive medical impacts in the lives of people suffering from these conditions e.g. Dravet syndromeGlaucomaTourette’s Syndrome.

Concurrently, the US government has restricted research on medical cannabis for many years. The government traditionally restricts access to a monopolised supply of low quality cannabis despite FDA-approval for clinical trials.  Perhaps, it is unsurprising that a lack of evidence still exists. However, more recently there has been a loosening of regulations and a FDA-approved trial for PTSD is currently in progress.    Perhaps incentivising industry investment in research and development should be considered as a means of fostering the development of safe and effective cannabinoid-based medicines.

Whilst Dr. Smyth considers the bill “more liberal than the most laissez-faire legislation anywhere else in the world”it is arguably one of the most restrictive e.g. not allowing personal cultivation which is allowed in many American states and many countries around the world. Recently, one German patient harvested his first legal crop of cannabis after securing the right to grow in German courts due to the prohibitive cost of his cannabinoid-based medicine treatment. This right will expire when cannabinoid-medicines will be reimbursed through health insurance. Issues around the right of patients to grow and general reimbursement will need to be addressed at Committee stage.

Dr. Smyth suggests that the certification procedure stipulated by the bill will be less onerous than a normal prescription.  However, in Canada, where a certification system is practised, the original paperwork, stretched over dozens of pages, and the application procedure could take up to a year. Hopefully, those mistakes will not be repeated here.  

Dr. Smyth and Dr. Harty both noted that Section 42 would essentially legalise cannabis by removing it from the Misuse of Drugs Acts.  This section is likely to be amended so that cannabis will not be removed from the Misuse of Drugs Acts, but rather re-scheduled.  Currently, it rests in Schedule I- rendering it more ‘controlled’ than opium, methadone, cocaine, heroin and methamphetamine which are all Schedule II substances. Arguably,  cannabinoid-based medicines should be scheduled  closer to benzodiazepines which are found in Schedules III and IV.  Benzodiazepines are more cognitive-impairing, more likely to cause dependence, and generally more dangerous than cannabinoid-based medicines.

Dr. Harty noted that the ‘Barnes’ report found that cannabis-based medicines should not be smoked as  “there are safer ways to administer it, such as orally, by vapour or oromucosal spray or in food”. The vaporisation of cannabis through products like Storz und Bickel’s® Volcano medically-approved inhalation system is associated with fast, safe and needs-adjustable dosing. This effect can be of utility in conditions like pain, spasms,  spasticity, nausea and lack of appetite where immediate effect may be needed.

Dr. Smyth’s suggests that Sativex® and presumably Epidiolex® -both cannabinoid-based medicines produced by the UK-based company GW Pharmaceuticals®– are the answer.  Sativex® is considered too expensive by the Irish National Centre for Pharmacoeconomics.  Epidolex® is probably similarly priced.  The proposed legislation would initially allow other trans-national suppliers like Tilray® and Bedrocan® to import their products and compete for the market.  Concurrently,  an Irish-based industry should be encouraged to develop which can  produce similar pharmaceutical grade cannabinoid-based medicines.

Dr. Smyth states: It would be great if there was a legislative method which ensured that other, evidence-based medicines that contain some THC could be prescribed by prudent doctors.”

There it is Dr. Smyth, it’s called an amended cannabinoid-based medicines Regulations bill!